InteliQ
InteliQ Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
1manufacturer
50catalogue numbers in this listing
26510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-02 |
| Record revised | 2023-01-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -70 to -20 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12009962 | In distribution | |
| 12009942 | In distribution | |
| 12009960 | In distribution | |
| 12008256 | In distribution | |
| 12008290 | In distribution | |
| 12019558 | In distribution | |
| 12009948 | In distribution | |
| 12009956 | In distribution | |
| 12008257 | In distribution | |
| 12008289 | In distribution | |
| 12008279 | In distribution | |
| 12016486 | In distribution | |
| 12008302 | In distribution | |
| 12009961 | In distribution | |
| 12009957 | In distribution | |
| 12009963 | In distribution | |
| 12008300 | In distribution | |
| 12009997 | In distribution | |
| 12009941 | In distribution | |
| 12009966 | In distribution | |
| 12008258 | In distribution | |
| 12009996 | In distribution | |
| 12009959 | In distribution | |
| 12009950 | In distribution | |
| 12015707 | In distribution | |
| 12016484 | In distribution | |
| 12015709 | In distribution | |
| 12016485 | In distribution | |
| 12008291 | In distribution | |
| 12015705 | In distribution | |
| 12008277 | In distribution | |
| 12016487 | In distribution | |
| 12009958 | In distribution | |
| 12008276 | In distribution | |
| 12009964 | In distribution | |
| 12008280 | In distribution | |
| 12015706 | In distribution | |
| 12009949 | In distribution | |
| 12008292 | In distribution | |
| 12008301 | In distribution | |
| 12015708 | In distribution | |
| 12009955 | In distribution | |
| 12008299 | In distribution | |
| 12008278 | In distribution | |
| 12009995 | In distribution | |
| 12009951 | In distribution | |
| 12009944 | In distribution | |
| 12009943 | In distribution | |
| 12008259 | In distribution | |
| 12009965 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| Validate | LGC Clinical Diagnostics, Inc. | 120 |
| Lyphochek | Bio-Rad Laboratories Inc. | 39 |
| Stat Profile | Nova Biomedical Corporation | 38 |
| i-STAT | Abbott Point OF Care Inc. | 24 |
| Multichem AE | Techno-Path Manufacturing Ltd. | 20 |
| Serum Control | Chromsystems Instruments & Chemicals Gmbh | 18 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 16 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
| Rap/Tac/CsA Control | More Diagnostics Inc. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163015 | 2017-01-10 |
| K150300 | 2015-12-11 |
| K143379 | 2015-03-13 |
| K141073 | 2014-06-23 |
| K140916 | 2014-05-06 |
| K140764 | 2014-04-25 |
| K134013 | 2014-04-24 |
| K133960 | 2014-01-22 |
| K132227 | 2013-10-25 |
| K130963 | 2013-05-06 |
| K130761 | 2013-04-12 |
| K130162 | 2013-03-01 |
| K123775 | 2013-01-31 |
| K123663 | 2012-12-27 |
| K123198 | 2012-11-20 |
| K122838 | 2012-10-17 |
| K082036 | 2008-09-08 |
| K073080 | 2008-01-24 |
| K071675 | 2007-07-03 |
| K043108 | 2004-12-07 |
| K042335 | 2004-09-17 |
| K040822 | 2004-05-19 |
| K040277 | 2004-03-10 |
| K040273 | 2004-03-04 |
| K022041 | 2002-07-16 |
| K020817 | 2002-04-12 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-04-15 | Class III | Material/Component Contamination | The Liquichek” ToRCH Plus IgM Control – Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product. | 211 boxes and 5 MiniPaks | 2013-08-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.